Embolic Protection Device and Method of Use

ABSTRACT

There is disclosed a porous emboli deflector for preventing cerebral emboli while maintaining cerebral blood flow during an endovascular or open surgical procedure. The device prevents the entrance of emboli of a size able to cause stroke (greater than 100 microns in the preferred embodiment) from entering either the right or left carotid arteries by deflecting emboli downstream in the blood flow. The device can be placed prior to any manipulation of the heart or aorta allowing maximal protection of the brain during the index procedure. The device has a low profile within the aorta which allows sheaths, catheters, or wires used in the index procedure to pass. Also disclosed are methods for insertion and removal of the device.

INCORPORATION BY REFERENCE

The entirety of US Published Application US2008/0065145 A1 is incorporated by reference herein, as if set forth fully herein.

The entirety of International Application WO2008/033845 A2 is incorporated by reference herein, as if set forth fully herein. In the event that this application is deemed not to be a US Published Application, the full text is set forth in the Appendix hereto, which is a part of this application.

BACKGROUND OF THE INVENTION

Endovascular procedures are being used more and more frequently to treat various cardiac and vascular surgical problems. Blocked arteries can be treated with angioplasty, endarterectomy, and/or stenting, using minimally invasive endovascular approaches. Aneurysms can be repaired by endovascular techniques. Another use for endovascular surgery is the treatment of cardiac valvular disease. Valvuloplasties are already being done endovascularly and percutaneous valve replacement is being tested in the United States and two devices are already approved for use in Europe. A major problem which is common to all these endovascular manipulations is that plaque found in the diseased vessels and valves can be dislodged and result in embolization. A major drawback to endovascular treatment of cardiac valves or the thoracic aorta is that the dislodged debris can embolize into the carotid vessels resulting in catastrophic consequences such as stroke or even death. Any procedure involving the passage of catheters across the aortic arch carries this risk of causing carotid emboli. Attempts have been made to protect the cerebral vasculature with filters and other devices. The majority of devices described are filters. The problems with filters include difficulty in placement and retrieval as well as the possibility that a filter will fill abruptly causing blockage of the artery prior to removal of the filter. Cerebral protection requires placement of filters in the carotid arteries, which has the additional drawback of manipulation of the carotid vessels during filter placement while the cerebral vasculature is still unprotected. The risk of stroke for a carotid arteriogram done by cannulation of the carotid artery is 1% compared to an arteriogram done from injection into the aorta without selective cannulation which carries minimal risk. The risk of cannulating a carotid artery, navigating a catheter containing a filter into position, and deploying the filter would likely carry an even higher stroke risk. Patients requiring cardiac or aortic arch procedures are high risk candidates for having carotid disease. These procedures simultaneously place both carotid arteries at risk for emboli. The chance of causing a stroke by the placement of a protective device into both carotid arteries makes the risk of using these devices prohibitive. The time and skill necessary to selectively cannulate both carotid arteries for filter placement has also contributed to the decision not to use them despite the stroke risk of unprotected cardiac and aortic arch procedures.

Only a small number of devices have recently been developed which are designed to protect both carotid arteries at the same time. One device to date has come to market which protects both carotid arteries from emboli. The Edwards Lifesciences' EMBOL-X is a device designed for use in open heart surgery during cardiopulmonary bypass. The device is a filtering screen inserted directly into the ascending aorta immediately beyond the heart, similar to a dryer vent screen. This screen filters all blood exiting the heart and bypass machine prior to allowing it to pass to the downstream circulation. Limitations of this device include its applicability only to open heart surgery, excluding its use in the vast array of endovascular procedures requiring protection. Adoption of the device has been hampered by ease of use, as operators often find it cumbersome. The device could not be adapted to endovascular procedures as the EMBOL-X completely spans the aorta. Thus wires or catheters could not pass by it without breaking its protective seal. It has found limited adoption, and is chiefly employed for high risk patients undergoing open heart surgery. NeuroSonix Ltd. has developed the EmBlocker™, an ultrasound based scheme to deflect emboli away from the cerebral circulation during open cardiac procedures. An ultrasound probe is placed through the sternal wound and ultrasonic energy is directed at the blood flow in the aortic arch with the intent of deflecting emboli away from the cerebral circulation. Another proposed version for use in endovascular procedures is in the form of an externally applied “collar” around the neck of the patient, which would apply ultrasound through the neck with the hope of deflecting embolic particles away from the carotid circulation. It is known that the ultrasound beam can be tolerated only for brief periods of time and that it is turned off and on at different points during procedures. Thus there would be a lack of complete protection from beginning to end of an open heart procedure or endovascular procedure.

One additional device being developed for aortic embolic protection is the SagaX AEPD which is placed in the aorta through a femoral artery and secured in position with wire bows pressing against the wall of the aorta and another vessel wall. A key difference and disadvantage of this device is that, when it is positioned to cover the vessels of the aortic arch, one of its bows spans the aorta. Although a catheter from the index procedure might be able to pass through the open loop of the bow there is the possibility for entanglement, of dislodging the device, or of pressing against the bow causing damage to the aortic wall. Another difference and disadvantage of this device includes its delivery through the as yet unprotected aorta. The device is delivered across the aortic arch, which could cause emboli, and is manipulated into position in the arch with deployment of its bows against vessel walls while the aorta is unprotected. Other differences and disadvantages include possible difficulty in positioning, difficulty in sealing it in position, and possible trauma to the vessel walls from the pressure of the bows.

The Embrella Device described in this patent is an embolic protection system intended to reduce the amount of embolic material that may enter the carotid arteries during endovascular procedures involving the passage of catheters across the aortic arch. It may also be used for other endovascular procedures and open surgical procedures. It has many advantages for use with endovascular cardiac and aortic procedures. It is placed through an artery of the arm separate from the femoral insertion site of index procedure catheters and devices. It uses a 6 French sheath. It is easy to place using standard Seldinger technique. It is easy to deploy in the aorta where it self-aligns and can be secured in position covering the ostia of both the brachiocephalic and left common carotid arteries. It is able to be placed before the index procedure is begun and can remain in place, providing embolic protection, until the procedure is completed. It has a very low profile in the aorta so that wires, catheters, and sheaths can pass by it without interaction. It is able to deflect emboli greater than 100 microns in diameter away from the carotid arteries thus protecting the patient from potentially devastating neurological consequences of these emboli. Because it is designed so that one size fits all, it can be kept available in stock.

BRIEF DESCRIPTION OF THE INVENTION

The Embrella shield deploys via a brachial or radial approach into the aorta to cover the ostia of the brachiocephalic and left common carotid arteries. The purpose of the device is to shield the carotid arteries from embolic debris that is knocked loose during procedures carried out in the aorta and/or heart while allowing blood flow to the brain through these arteries. The device is intended to be collapsed into a loader, backloaded past the hemostasis valve of a 6F sheath, and then advanced through the sheath until it deploys in the aorta and is positioned for deflection. The device has an oval shape which self-aligns in the aorta and allows for coverage of the ostia of both the brachiocephalic and left common carotid arteries.

DETAILED DESCRIPTION OF THE INVENTION Nitinol Frame:

A preferred embodiment of the nitinol frame is built from a single laser-cut piece of material. The frame can also be built from separate wires that are formed and welded together. The frame is formed so that it is intentionally bent back into a boat-like shape to press against the aortic wall when it is deployed. When laid flat, the frame measures 60 mm along its long axis to ensure coverage of both the brachiocephalic and left common carotid artery over a wide range of anatomies. It could also be made a different size. There are three thicknesses along the perimeter of the frame to provide varying stiffness as needed. The thinnest sections at each end are critical to function—the way the device collapses would cause the nitinol to permanently deform if they were thicker, which is a gating issue for working in the 6F profile. The deploy/collapse sequence emanates from the central struts and continues to the tips of the device. One benefit of this design is that the physician can visualize the tips as they deploy, somewhat like a blooming flower.

Another benefit is that the device does not reach straight across the aorta or touch the wall of the lesser curvature of the aorta while deploying. There are holes in the frame for radiopaque markers to be loaded—one at each petal tip and one on the shaft for alignment with the sheath marker. The radiopaque markers on the frame tips and on the shaft as well as the visibility of the nitinol frame itself aid in placement guidance. The frame is attached to the shaft via an interlocking feature cut into each of the central struts near the proximal end. Acting somewhat like a puzzle piece, this mechanical engagement ensures sufficient strength for deployment, manipulation and retrieval of the device. A segment of hypodermic tubing is crimped and bonded in place over the connection for added stability. This also houses the shaft RO marker and proximal end of the sutures that aid in retrieval.

The frame of the device of the present invention may alternatively be formed by injection molding, cold forming, casting, or any other suitable method, or combination of methods, or the frame may be formed to assume the desired conformation upon inflation, heating, cooling, or exposure to body fluids.

The radiopaque markers disposed on the frame may be plated to the frame surface, may be painted thereon, dyed, applied as a wire wrap or coil, or any other suitable radiopaque technique. The position of the markers may be offset from the major axis of the frame to permit proper folding of the frame.

Membrane:

The membrane is a laser drilled polyurethane (100μ pore size) film that allows for blood flow, but deflects emboli of critical size. The membrane is heparin coated. It may also be uncoated or coated with another substance. The attachment of the membrane to the nitinol frame in the preferred embodiment of the device is accomplished by wrapping the polyurethane around the wire and heat bonding it to itself. Other options for attachment include using a polyurethane dispersion to coat the nitinol frame then heat bonding the film to it, adhesive bonding, suturing, and/or ultrasonic welding.

The membrane of the device may be formed from materials including, but not limited to PET, PETE, PETN, PTFE, EPTFE with a high internodal distance, and the membrane may be optionally filled or coated with a radiopaque material, and may be woven, airlaid, or film-formed. The membrane may be attached to the frame by any suitable means including chemical bonding, heat bonding, sutures, and interference fit such as by a double frame trapping the membrane material. The membrane may have either uniform or non-uniform pore sizes and areal distributions and patterns.

Shaft:

The shaft is constructed of a solid nitinol wire which gives it flexibility and strength. The shaft is 110 cm in length to allow for manipulation through sheaths as long as 90 cm. It could also be of different length. It has a minimally sized (0.035″ diameter) so that the interventionalist can flush contrast between the shaft and the sheath to confirm position of the shield.

Alternatively, the shaft may be any other suitable material including polymer or stainless steel, and may be solid, coil, or composite. Optionally, the shaft may be provided with a handle disposed at its distal end.

Suture

Standard, monofilament nylon suture is used as an aid for retrieval. A loop of suture is trapped by the membrane heat-bond and acts to lead the membrane into the sheath during retrieval. Alternatively, the suture may be replaced by any suitable retrieval aid such as an extension of the membrane itself.

Torquer

The torquer is used to stabilize the device during packaging, and also as an accessory to help grip and manipulate the shaft during use. It is a standard product used to grip guide-wires up to 0.038″ in diameter and employs a simple rotating clamp to lock onto the shaft. The function is similar to a pin-vise.

Loading Tool

The loading tool is a blunt-tipped, 6F introducer sheath that allows for the device to be flushed and back-loaded. It consists of a silicone hemostasis valve connected to a flush port (with stopcock) and length of Pebax tubing. The device is initially collapsed into the loading tool to evacuate all air and provide a means of passing the hemostasis valve at the proximal end of the sheath.

The present invention comprises a deflector umbrella. In use, the device is placed into the aortic arch by the Seldinger or other technique, through the right arm using either a brachial or radial artery approach. It is advanced to the ostium of the brachiocephalic artery where it is deployed in the aortic arch. The device is then pulled back into position to cover the ostia of both the brachiocephalic and left common carotid arteries. A slow flush of contrast confirms the seal over these two head vessels. The device can remain in place throughout the emboli causing index procedure and then is removed. Alternatively, the device may be emplaced using an aortic puncture, direct surgical placement, or similar route.

The device is retrieved into the sheath by simply pulling back on the shaft relative to the sheath. The central struts fold together in the first action, then a second fold occurs as the sheath forces the petal tips to be closed together. Once the device is fully captured inside of the sheath, the user continues to withdraw it through the hemostasis valve at the proximal end. Variations on the procedure could be employed to minimize intimal damage and/or potential for release of emboli during retrieval. One such procedural variation would be for the user to advance the device and sheath tip into the aorta near the lesser curve of the arch, then re-sheath the device in that location.

A radiopaque marker may be provided on the shaft itself to allow visualization of when the device is fully deployed from the delivery catheter.

BRIEF DESCRIPTION OF THE FIGURES

The deflector “Embrella” of the present invention is positioned prior to any manipulation of the heart or aortic arch. It is simple to place and carries only the minimal risk of catheterizing the aorta through the arm. The device is opened in the aortic arch and positioned to cover the ostia of both the brachiocephalic and left common carotid arteries. This position prevents emboli from entering the cerebral circulation through either the right or left carotid arteries with one simple device. Any emboli from the cardiac or aortic procedure are deflected downstream. The device, due to its low profile in the aortic lumen, allows passage of catheters, sheaths, or wires used in the index procedure. After the procedure is complete, the device is preferably retracted into the sheath while in the aorta, covering the device prior to withdrawal. Should any clot or debris be attached to the outer side of the device, it will be captured in the closed device and withdrawn. A preferred embodiment of the device is composed an oval nitinol frame with an adequate diameter of about 60 mm to cover the ostia of both the brachiocephalic and left common carotid arteries. This device could be modified in size in another embodiment in order to be used to cover the ostia of different vessels, including all three head vessels including the left subclavian artery. Such a device may be asymmetric in the major dimension. Alternatively, a smaller device may be deployed to cover the ostium of only one vessel. The porous membrane attached to the center of the frame is made of a polyurethane with about 100 micron or smaller pores to allow the flow of blood into the cerebral circulation, but able to deflect and/or trap emboli of a size which could cause a stroke. The frame of the device is preferably a nitinol wire, allowing a good seal with the curved aortic wall. The center of the device may comprise a porous membrane or screen, which fits more snugly against the aortic wall, with a very small profile, further preventing resistance to downstream aortic blood flow. In profile, the device may be flat, concave, or convex. The device opens as a result of its construction material, nitinol, elastically resuming its shape after being released from its sheath. Retrieval involves simply retracting the device back into the sheath by pulling on it, or by first advancing it slightly to separate the edges from the vessel wall before pulling back.

Arm Insertion of the Device:

Referring now to FIG. 1 (from the incorporated published application), the deflector is delivered via percutaneous insertion into the right brachial or radial artery and is guided into the aortic arch. There it is deployed and then pulled back into position to cover the ostia of the innominate and left common carotid arteries. The device deflects emboli during aortic and cardiac procedures, allowing the flow of blood through into the cerebral circulation (carotid arteries) but not permitting the passage of emboli greater than 100 microns.

Deployment of the Device via Arm Approach:

Percutaneous access to the circulation via the right arm through the radial or brachial artery is performed and a wire guided into the aortic arch after exiting the innominate artery. The device is inserted into a loading tool, then into a 6F sheath, placed over the wire, and guided into the aortic arch. The device is pushed out of the sheath and then opened in the aortic arch (FIG. 12). The device is pulled back into position, covering the ostia of both the innominate and left common carotid arteries. The device allows the passage of blood through to the carotid arteries, but deflects emboli generated by aortic or cardiac procedures away from these arteries. At the completion of the debris producing concomitant procedure, the device is closed. Preferably, the device is then withdrawn into a covering sheath (FIG. 14) to encapsulate it prior to removal from the arm access artery. Any trapped debris is enfolded within the closed device, safely and securely within the covering sheath.

Embolic Deflecting Device:

Referring now to FIG. 14, the device opens by “blooming” its two lobes or “petals” as the shaft is extended beyond the sheath. In this manner, the device does not contact the aortic wall, and thus, does not contribute to dislodgement of embolic particulate debris during emplacement. The same mechanism is true during retrieval. Referring now to FIG. 15, the deflector of the present invention, viewed from above, is oval shaped with a diameter of 60 mm to cover the ostia of both the brachiocephalic and left common carotid arteries in most patients. It can also be made a different size. It is composed of a nitinol frame supporting a membrane made of a polyurethane laser drilled with 100 micron pores (or another size pores) to allow the flow of blood, but deflect or trap emboli of a size which could cause a stroke. The frame of the device is a flexible nitinol skeleton allowing a good seal with the double curvature of the aortic wall. The device opens as a result of the material from which it is made, nitinol, resuming its shape after being released from its sheath. The device is oval to assist in sealing of the edge against the wall of the aorta, covering the ostia of both the brachiocephalic and left common carotid arteries and maintaining a low profile within the lumen of the aorta. The center of the device is a porous membrane which, like a screen, fits snugly against the aortic wall, with a very small profile, further preventing resistance to flow in the aorta and also allowing passage of index procedure wires, catheters and sheaths. This device could be modified in size or shape in another embodiment in order to be used to cover the ostia of different vessels. The device is coated with heparin to prevent clotting, but may be uncoated or coated with another substance. The device is provided with radioopaque markers shown in FIG. 16.

During deployment, the device may be locked in position related to the sheath using a rotating valve or similar mechanism. The sheath is preferably held in position at the skin using Tegaderm. The device remains tethered by the shaft, and tensioned against the vessel wall by application of force external to the patient. The device and/or shaft may be elastic to accommodate movement or shifting during use, so as to maintain protection of the head vessels. The device is preferably tethered to permit repositioning or removal at any time.

While the invention has been described in its preferred embodiment, it is to be understood that the words which have been used are words of description rather than of limitation and that changes may be made within the purview of the appended claims without departing from the true scope and spirit of the invention in its broader aspects. Rather, various modifications may be made in the details within the scope and range of equivalents of the claims and without departing from the spirit of the invention. The inventor further requires that the scope accorded the claims to be filed be in accordance with the broadest possible construction available under the law as it exists on the date of filing thereof and that no narrowing of the scope of the appended claims be allowed due to subsequent changes in the law, as such a narrowing would constitute an ex post facto adjudication, and a taking without due process or just compensation. 

1. A embolus deflector for protecting against cerebral embolization comprising a blood flow permeable covering extending over either (a) the ostia of the right common carotid and left common carotid arteries, or (b) the ostia of the brachiocephalic and the left common carotid arteries.
 2. The deflector of claim 1 wherein the deflector is capable of being inserted and placed through a catheter in an artery of the arm of a patient.
 3. The deflector of claim 2 wherein the artery is the brachial artery of a patient.
 4. The deflector of claim 1 wherein the deflector is capable of being inserted and placed through a catheter in the femoral artery of a patient.
 5. The deflector of claim 1 wherein the deflector is capable of being inserted and placed directly into the aorta of a patient during an open surgical procedure.
 6. The deflector of claim 1 wherein prior to withdrawal, the deflector may be inverted, trapping debris.
 7. The deflector of claim 1 wherein prior to withdrawal, the deflector may be closed, trapping debris.
 8. The deflector of claim 1 wherein the periphery is adapted to seal against the walls of the aortic arch.
 9. The deflector of claim 6 wherein the periphery is supported by a flexible member.
 10. The deflector of claim 8 wherein the periphery is supported by a member constructed from one or more materials selected from the group comprising: nitinol, Elgiloy, stainless steel, plastic, PTFE, ePTFE, polyester, nylon, silicone, and titanium.
 11. The deflector of claim 8 wherein the shape of the periphery is selected from the group comprising: round, oval, square, rectangular, elliptical, and edge-scalloped and irregular.
 12. The deflector of claim 11 wherein the profile of the deflector in side view is selected from the group comprising: flat, rounded, peaked, onion shaped, tent shaped, parachute shaped, conic, cylindrical, plateau, disc shaped (flat, concave, convex, or concave-convex, and spherical.)
 13. The deflector of claim 11 wherein a supporting member protrudes from the top surface and extends to the opposite wall of the aortic lumen when the deflector is in place.
 14. The deflector of claim 1 further comprising a locking means.
 15. The deflector of claim 14 wherein the locking means is selected from the group comprising: a clamp, a twist screw without ratchet, a twist screw with ratchet, a balloon, and a stent-like sleeve.
 16. A method of employing an emboli deflector to cover either (a) the ostia of the right common carotid and left common carotid arteries, or (b) the ostia of the brachiocephalic and the left common carotid arteries comprising the steps of: a. Accessing the circulation through percutaneous insertion of a catheter into an artery; b. Guiding a wire through the artery into the aortic arch; c. Placing a collapsed deflector in a sheath over the wire, and guiding the deflector into the aortic arch; d. Withdrawing the sheath from the deflector, exposing the deflector to aortic blood flow, and expanding the deflector; and e. Positioning the deflector to cover either (a) the ostia of the right common carotid and left common carotid arteries, or (b) the ostia of the brachiocephalic and the left common carotid arteries.
 17. The method of claim 16 further comprising the steps of: f. Performing a surgical procedure; g. Inverting the deflector into a sheath or closing it in a manner to trap any debris or clot remaining on the device surface; and h. Withdrawing the inverted or closed deflector from the patient.
 18. The method of claim 16 wherein step (a) comprises accessing the circulation through percutaneous insertion of a catheter into an artery of the arm; and step (b) comprises guiding a wire through the artery into the aortic arch via the innominate artery;
 19. The method of claim 18 further comprising the steps of: f. Performing a surgical procedure; g. Inverting the deflector into a sheath or closing it in a manner to trap any debris or clot remaining on the device surface; and h. Withdrawing the inverted or closed deflector from the patient. 